Quality Systems Associate

Company: Grifols

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary

Under the direct supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with internal and external regulations and protocol.

Primary Responsibilities

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to product quality and/or donor safety.
• Inspects and releases incoming supplies. Investigates and reports supplies that have not met quality specifications and requirements prior to use.
• Performs documentation review for unsuitable test results.
• Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs, and regulatory requirements are followed.

Additional Responsibilities

• Performs all product release activities.
• Reviews lookback information and documentation.
• Reviews waste shipment documentation.
• Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process.
• Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
• Reviews donor deferral notifications from competitor centers.
• Reviews plasma processing documentation to ensure the proper freezing, storage, and handling of product.

Training Program Support

• Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training program documents.
• Creates, maintains, and audits training records and files to ensure compliance.
• Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
• Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
• When the Quality Systems Manager is absent, the Quality Systems Associate may be required to perform the following duties:
• Reviews and approves deferred donor reinstatement activities.
• Assists with completion of the internal donor center audit.

Job Description Overview

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Knowledge, Skills, and Abilities

• Developing command of interpersonal communication, organizational, and problem-solving skills.
• Ability to understand FDA regulations.
• Strong integrity and commitment to quality and compliance.
• Good knowledge of mathematics.
• Legible handwriting.
• Proficiency with computers.
• Ability to work flexible scheduling to meet business needs.
• Ability to perform basic document review and employee observations.
• Ability to understand and follow SOPs and protocols.
• Basic understanding of cGMP and quality systems.

Education

High school diploma or GED. Obtains state licensures or certifications if applicable.

Experience

Typically requires no previous related experience.

Occupational Demands

Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves, and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Light lifting of 15lbs. with a maximum lift of 50lbs. Hearing acuity essential. Able to communicate information and ideas effectively.

Third Party Agency and Recruiter Notice

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Equal Employment Opportunity

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.

Location

NORTH AMERICA : USA : MO-St. Louis

Learn more about Grifols.